Don’t Just Do Something, Stand There?
Unraveling the Complexities of Riata
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As electrophysiologists we confront the challenge of articulating the risks and benefits of various management options to our patients and their families. Weighing the upfront risk typically associated with an interventional procedure against potential adverse events in the long term is a vexing problem that we frequently face in clinical practice. This discussion involves both the immediate risks of an intervention (doing something) and the protracted risks of observation (standing there). Assessing the risk-benefit ratio of intervening today versus possibly intervening tomorrow when a device malfunction has already occurred is challenging to the experts in the field, let alone patients and their families. It is therefore not too surprising that we often find ourselves, after a long discussion in which we present the salient medical facts and evidence-based reasoning to our patients, we face the question, “What would you do if I was your family member?” Management of implantable cardioverter-defibrillator leads with a known high rate of failure is anxiety-producing for both patients and physicians.
See Article by Parkash et al
Many of our patients continue to live with the St Jude Medical Riata family of leads, which were placed under US Food and Drug Administration advisory in 2011. These leads have well-described design problems associated with a tendency toward inside-out abrasion, resulting in conductor cable externalization. They also display an increased rate of electrical failure, although the rate of failure and its relationship to conductor cable externalization have been debated. Although most observational studies have shown a …